ILD OSANCT05838183
Interstitial Lung Disease and Obstructive Sleep Apnea
An observational study of ILD OSA, run by Dan Liu at 1 site in China.
Trial summary
Clinically, all patients with interstitial lung disease(ILD) were observed, and relevant clinical data were collected. Bronchoscopic specimens were collected according to the condition of the enrolled patients, and the rapid on site evaluation(ROSE) was evaluated, combined with the metagenomic next generation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ILD OSA
- What is being tested?
- The relationship between imaging and ROSE and NGS
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Interstitial lung disease and respiratory sleep apnoea
Who may be able to join
- over 18 years old and under 80 years old.
- Clinical diagnosis of interstitial lung disease or obstructive respiratory sleep apnea syndrome.
- Patient is conscious and capable of signing informed consent.
- The patient may wear a polysomnograph.
Who cannot join
- malignant tumors.
- severe heart failure.
- uremia.
- autoimmune diseases.
- pulmonary embolism, and end-stage chronic obstructive pulmonary disease.
- Patients with mental illnesscannot sign informed consent on their own.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300000
Dan Liu, liudan_nkdx@163.com, liudan_nkdx@163.com
Jing Feng, jingfeng_zyy@126.com, jingfeng_zyy@126.com
About this study
Official title: Study on the Clinical Characteristics of Interstitial Lung Disease and Obstructive Sleep Apnea
Clinically, all patients with interstitial lung disease(ILD) were observed, and relevant clinical data were collected. Bronchoscopic specimens were collected according to the condition of the enrolled patients, and the rapid on site evaluation(ROSE) was evaluated, combined with the metagenomic next generation sequencing(mNGS) results of these patients. To observe the etiology and biological characteristics of exacerbation in patients with interstitial lung disease.
All patients undergo polysomnography (PSG) and drug-induced sleep endoscopy(DISE). The biological specimens was obtained for molecular biology or other tests.We detected ZNF331, Claudin1, Claudin2, Claudin3, Claudin4, and IL22 as biomarkers to differentiate the diagnostic efficiency of OSA in ILD, ILD+OSA, OSA, and Ctrl groups, respectively
- Conditions
- ILD OSA
- Being tested
- The relationship between imaging and ROSE and NGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The relationship between imaging and ROSE and NGSDiagnostic test
Also called Association between the severity of OSA and biological specimen examination
The correlation between ROSE and NGS in imaging and bronchoscopy of ILD patients was observed
| Study group | Role | What they receive |
|---|---|---|
| ILD with OSA group | ILD patient diagnosed with OSA by PSG. Bronchoscopy was performed to obtain alveolar lavage fluid in ILD patients and lung tissue was obtained for ROSE and mNGS in appropriate patients Receives: Diagnostic Test: The relationship between imaging and ROSE and NGS | |
| ILD without OSA | ILD patients excluded OSA through PSG. Bronchoscopy was performed to obtain alveolar lavage fluid in ILD patients and lung tissue was obtained for ROSE and mNGS in appropriate patients Receives: Diagnostic Test: The relationship between imaging and ROSE and NGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
imaging changes and ROSE and NGS in patients
Relationship between imaging changes and ROSE and NGS in patients with interstitial lung disease
Measured: 2Day
Secondary outcomes (1)
Severity and biological examination of OSA patients
Classification of the severity of OSA and the relationship between positive results of biological or other tests
Measured: 2Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Sep 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ILD OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Liu, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838183
- Sponsor's protocol ID
- Dliu
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Clinical Characteristics of Interstitial Lung Disease and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05838183
- Acronym / sponsor ID
- Dliu
- Conditions
- ILD OSA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dan LiuUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinically, all patients with interstitial lung disease(ILD) were observed, and relevant clinical data were collected. Bronchoscopic specimens were collected according to the condition of the enrolled patients, and the rapid on site evaluation(ROSE) was evaluated, combined with the metagenomic next generation sequencing(mNGS) results of these patients. To observe the etiology and biological characteristics of exacerbation in patients with interstitial lung disease.
All patients undergo polysomnography (PSG) and drug-induced sleep endoscopy(DISE). The biological specimens was obtained for molecular biology or other tests.We detected ZNF331, Claudin1, Claudin2, Claudin3, Claudin4, and IL22 as biomarkers to differentiate the diagnostic efficiency of OSA in ILD, ILD+OSA, OSA, and Ctrl groups, respectively
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILD with OSA group | – | Diagnostic Test: The relationship between imaging and ROSE and NGSILD patient diagnosed with OSA by PSG. Bronchoscopy was performed to obtain alveolar lavage fluid in ILD patients and lung tissue was obtained for ROSE and mNGS in appropriate patients |
| ILD without OSA | – | Diagnostic Test: The relationship between imaging and ROSE and NGSILD patients excluded OSA through PSG. Bronchoscopy was performed to obtain alveolar lavage fluid in ILD patients and lung tissue was obtained for ROSE and mNGS in appropriate patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Interstitial lung disease and respiratory sleep apnoea
Key inclusion criteria (4 listed)
- over 18 years old and under 80 years old.
- Clinical diagnosis of interstitial lung disease or obstructive respiratory sleep apnea syndrome.
- Patient is conscious and capable of signing informed consent.
- The patient may wear a polysomnograph.
Key exclusion criteria (6 listed)
- malignant tumors.
- severe heart failure.
- uremia.
- autoimmune diseases.
- pulmonary embolism, and end-stage chronic obstructive pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The relationship between imaging and ROSE and NGSAlso: Association between the severity of OSA and biological specimen examinationThe correlation between ROSE and NGS in imaging and bronchoscopy of ILD patients was observed | Diagnostic test | ILD with OSA group, ILD without OSA |
Primary outcome
imaging changes and ROSE and NGS in patients
Time frame: 2Day
Relationship between imaging changes and ROSE and NGS in patients with interstitial lung disease
1 secondary outcome
Severity and biological examination of OSA patients
Time frame: 2Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Related trials for ILD OSA
RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ILD OSA, run by Dan Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Liu (13920701949, liudan_nkdx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
imaging changes and ROSE and NGS in patients (time frame: 2Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.